Obesity treatment tools and methods

ABSTRACT

Various obesity treatment tools and methods are described herein, as well as treatments for other gastric-related diseases, e.g., GERD. Treatment includes reducing the size of the stomach pouch to limit the caloric intake as well as to provide an earlier feeling of satiety. This may be done by creating a smaller gastric pouch within the stomach directly from the interior of the stomach itself. The smaller pouches may be made through the use of individual anchoring devices, rotating probes, or volume reduction devices. A pyloroplasty procedure may also be performed to render the pyloric sphincter incompetent. A gastric bypass procedure may additionally be performed using atraumatic magnetic anastomoses devices so that sugars and fats are passed directly to the bowel while bypassing the stomach. Many of these procedures may be done in a variety of combinations. Treatment may create enforced behavioral modifications by discouraging the ingestion of high-caloric foods.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of application Ser. No. 10/402,061,filed Mar. 27, 2003, now U.S. Pat. No. 7,503,922 which is a continuationof U.S. patent application Ser. No. 09/871,297, filed May 30, 2001,which is now U.S. Pat. No. 6,558,400, both of which are incorporatedherein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to tools and methods for thetreatment of obesity. More particularly, the present invention relatesto tools and methods for performing less traumatic gastroplastyprocedures.

2. General Background and State of the Art

Obesity is considered a major health problem with annual associatedcosts reaching $100 billion in the U.S. alone. Morbid obesity is acondition of obesity with the presence of a secondary debilitatingprogressive disease and is generally associated with a body mass index(BMI)≧40 kg/m². While the basic mechanism of obesity is simply animbalance between caloric intake and burn rate, the underlying factorsare varied and complex and conservative attempts at sustained weightloss with this population are almost always unsuccessful. Often, thereare genetic and other biological influences that may overrideenvironmental causes. Consequently, obesity is a disease that eludes asimple treatment, with a recurrence rate above 90% for those who attemptto lose weight. Moreover, long-term results using conservativetreatments for morbid obesity are generally unsuccessful and aretypically associated with further loss of self-esteem with the regainingof weight. Hypertension, cardiovascular disease, diabetes, along with ahost of other comorbidities all make morbid obesity second only tosmoking as a preventable cause of death.

Surgical procedures for obesity date back to 1889 (Billroth) with theearliest peer reviewed procedure being the jejuno-ileal bypass in 1954(Kreman). A successful procedure is commonly defined as one that resultsin at least 50% excess weight loss at 2 years. Today, the most commonlydone operation is the Roux-en-Y gastric bypass (RYGB), with around35,000 performed annually in the U.S. Other forms of bariatric surgeryinclude Fobi pouch, bilio-pancreatic diversion, and gastroplasty or“stomach stapling”. The single existing procedure that involves animplanted device is the Lap-Band, which is a laparoscopically installedinflatable cuff that is placed around the top of the stomach just belowthe lower esophageal sphincter (LES). This device affects satiety only(no reduced caloric absorption). Because there is more to obesity thansimple overeating, it is unlikely that Lap-Band by itself will ever beas effective as a surgery that includes other physiologic feedbackmechanisms.

The RYGB procedure is a procedure which has become very common inbariatric surgery. This procedure facilitates the movement of thejejunum to a high position by using a retrocolic Roux-en-Y loop. Theprocedure is generally performed through a 6-8 inch incision extendingfrom the end of the breastbone to just above the navel. The stomach iscompletely divided into 2 unequal portions (a smaller upper and a largerlower gastric pouch) using an automatic stapling device with the rawsurface reinforced with additional sutures. The upper pouch typicallymeasures less than about 1 ounce or 20 cc, while the lower larger pouchremains generally intact and continues to secrete stomach juices flowingthrough the intestinal tract.

A segment of the small intestine Oust distal of the duodenum or proximalof the jejunum) is then brought from the lower abdomen and joined withthe upper pouch to form an end-to-end anastomosis created through ahalf-inch opening, also called the stoma. This segment of the smallintestine is called the “Roux loop” and carries food from the upperpouch to the remainder of the intestines, where the food is digested.The remaining lower pouch and the attached segment of duodenum are thenreconnected to form another anastomotic connection to the Roux loop at alocation approximately 50-150 cm (1.6-4.9 ft) from the stoma, typicallyusing a stapling instrument. It is at this connection that the digestivejuices from the bypassed stomach, pancreas, and liver enter the jejunumor ileum to aid in the digesting of food. Due to the small size of theupper pouch, patients are forced to eat at a slower rate and aresatiated much more quickly, thereby reducing the caloric intake(typically between about 1000-1200 Calories).

Because the food enters the intestines directly, conditions known as the“dumping syndrome” are created when certain types of “junk foods” areconsumed (usually sweets and other simple carbohydrates). This createsunpleasant feelings of nausea, diarrhea, nervousness, and sweating,which in turn discourages patients from developing unhealthy eatingpatterns. With the RYGB procedure, a loss of at least 50% of excess bodyweight (EBW) is maintained in approximately 60% of patients at 5 yearswith a reduced complication rate than other procedures.

In creating the anastomoses in the RYGB procedure, several methods havepreviously been developed to maintain channel integrity. However, theconventional RYGB procedure requires a great deal of operative time andbecause of the degree of invasiveness, post-operative recovery time canbe quite lengthy and painful.

Aside from the RYGB procedure, another gastrointestinal disease whichrelates to the stomach is gastroesophageal reflux disease (GERD). Thelower esophageal sphincter is located in a distal portion of theesophagus adjacent to the junction between the esophagus and thestomach. When food is digested, a properly functioning lower esophagealsphincter would allow food to pass from the esophagus to the stomachwhile preventing reverse flow. However, GERD is a disorder where theesophageal sphincter allows the stomach contents, which includes gastricacid and bile, to flow back into the distal portion of the esophagus.Some complications associated with GERD include heartburn, pulmonarydisorders, chest pain, esophageal ulcers, esophagitis, Barrett'sesophagus, and esophageal carcinoma.

Common treatments for GERD include the administration of prescriptionacid blockers. But these drugs afford only short term relief;additionally, these drugs can be expensive and may have long-term sideeffects. Surgical procedures have included a procedure called the Nissenfundoplication, where a portion of the gastric fundus is wrapped aroundthe esophagus. The wrapped fundus applies pressure to the esophagus tolimit the reverse flow of the stomach contents. Effectively elongatingthe esophagus by fundoplication or by extending it via a staple line maybe done to treat GERD. Conventional fundoplication procedures may beeffective at treating GERD, but they also have disadvantages. Forinstance, many of these procedures require large incisions to be made ina patient. Laparoscopic procedures typically require several smallerincisions formed in the abdominal wall for the insertion of instrumentsinto the patient's body. However, such procedures can be expensive andthey can increase the risks of post-operative hernias, accidental organperforations, and other related drawbacks.

Examples related to the field of gastroplasty are described below.

U.S. Pat. No. 5,549,621 to Bessler et al., which is incorporated hereinby reference in its entirety, pertains to an apparatus and method forperforming vertical banded gastroplasty without the use of staples. Thedescribed device uses at least two clamping bars to create atubular-shaped pouch. However, the device is deployed laparoscopicallyonto the external surface of the stomach.

U.S. Pat. No. 5,382,231 to Shlain, which is incorporated herein byreference in its entirety, describes a device for transesophagealstomach retraction by a device having vacuum ports utilized to draw thestomach over the device. However, this device is used for manipulatingand retracting a patient's stomach from the inside during a variety ofsurgical procedures and is not a permanent procedure for creating aninternal pouch within the stomach itself.

U.S. Pat. No. 5,345,949 to Shlain, which is incorporated herein byreference in its entirety, relates to laparoscopic methods and tools forinserting a banding device to bring the walls of the stomach adjacent toone another between the proximal pouch and the distal region of thestomach. But there is no procedure for the creation of an internal pouchinternally created from the stomach.

Examples related to the field of GERD treatment are described below.

U.S. Pat. No. 6,159,146 to El Gazayerli, which is incorporated herein byreference in its entirety, relates to a device which is insertedtransesophageally and engages the inside anterior wall of the fundus andsecures it to the side of the esophagus.

U.S. Pat. No. 6,113,609 to Adams, which is incorporated herein byreference in its entirety, pertains to a system which includes placementof a distal anchor through a hole formed in the wall of the esophagusand through a hole formed in the gastric wall, which are then fastenedtogether.

U.S. Pat. No. 5,571,116 to Bolanos et al., which is incorporated hereinby reference in its entirety, pertains to an invagination device whichapproximates the lower esophagus and the fundus of the stomach.

However, all of these examples are limited to treatments for GERD whichinvolves the attachment of the fundus, or upper portion of the stomach,to the esophagus.

SUMMARY OF THE INVENTION

Various tools and methods of treatment for obesity are described hereinwhich are less traumatic and less invasive than procedures currentlyavailable. A variety of methods for the treatment of obesity, as well asother gastric-related diseases, e.g., gastroesophageal reflux disease(GERD), are disclosed. One method involves reducing the size of thestomach pouch to limit the caloric intake as well as to provide anearlier feeling of satiety. This may be done by creating a smallergastric pouch within the stomach. This procedure optionally may beenhanced by performing a pyloroplasty prior to and/or in conjunctionwith the pouch size reduction, i.e., rendering the pyloric sphincterincompetent. This increases the rate of stomach emptying, allowingsugars and fats to pass directly into the bowel, thereby inducingdumping. Moreover, the food in the stomach may be made to also bypass aproximal portion of the bowel, i.e., a portion of the duodenum andjejunum, by creating a gastric anastomosis thereby creating amalabsorption of sugars and fats which are mostly absorbed in thebypassed portion of the duodenum and jejunum. Sugars and fats enteringthe bowel directly from the stomach rather than passing through thepylorus and proximal duodenum and jejunum may cause “dumping” syndromeand diarrhea. This in turn may create enforced behavioral modifications,thereby discouraging the patient from eating these types of high-caloricfoods.

In forming a modified pouch, a marking device, such as a bougie, may beused at the beginning of the procedure, to create a dye marker “roadmap” on the interior surface of the stomach from the pylorus to theesophagus. This may enable visualization by, e.g., an endoscope, to givethe physician a clear reference point for staple or fixation elementplacement. A distal balloon, which is preferably attached to aninflation tip at a distal end, may be inserted into the pylorus tostabilize the bougie during the procedure and may be inflated from theproximal end of the tubing by the physician.

In reducing the stomach size, one variation involves grasping theinterior walls of the stomach, preferably via an endoscope advancedtransesophageally, and placing one to several individual fixationelements on opposing interior walls and then bringing those fixationelements together. The stomach pouch may be modified and/or created by avariety of other device variations utilizing other methods, e.g.,stapling opposing sides of a stomach together to form two separatelumens from within the interior surface of the stomach. An endoscopicstapling device may be used to accomplish such a task. Such anendoscopic stapler preferably brings two regions of tissue intoapposition and may then apply a fastening element, e.g., staples, clips,tags, screws, etc., into the two regions of tissue to affix themtogether.

In addition to endoscopically applied stapling and clip devices,rotating and rotatable probes may also be used to form a modifiedsmaller lumen within a main lumen. Such probes generally may be insertedinto a stomach endoscopically and may engage a portion of the interiorlining of the stomach and may then be rotated to roll the engagedportion of the stomach wall around the probe itself to bring the wall inapposition with another portion of the stomach wall. Such rotatingprobes may be used to create a blind-ended pouch of stomach within themain stomach lumen, or as with the other devices, may be used to createa smaller pouch exiting into the pylorus. Once the roll of stomach wallis brought into apposition, a row or a plurality of fasteners, e.g.,staples, blind staples, clips, tags, adhesives, screws, etc., may beused to maintain the stomach. Moreover, other variations may includegastric volume reduction devices as part of the present invention. Suchvolume reduction devices generally may be inserted into a stomachtrans-esophageally through the use of, e.g., an endoscope. The reductiondevice may be used to draw or engage a portion of the interior lining ofthe stomach; the drawn or engaged portion may then be eventuallyremoved, either actively or through natural processes, e.g., pressurenecrosis.

To aid in the overall effect, a pyloroplasty procedure may also beperformed to enhance treatment. The pyloroplasty may be performed priorto (preferable), in conjunction with, or following the gastric reductionprocedure. A pyloroplasty procedure typically results in the pyloricsphincter being rendered incompetent. Generally, a pyloroplasty devicemay be passed endoscopically through the esophagus, into the stomach,and preferably into position in or across the pylorus. Energy or astimulus is then preferably applied to the pylorus to render itincompetent.

Moreover, an additional anastomosis gastric bypass procedure may also beperformed to further enhance treatment. The anastomosis procedure may beperformed preferably prior to, in conjunction with, or following thegastric reduction and pyloroplasty procedures (if performed at all). Theprocedure generally involves endoscopically or laparoscopically creatinga side-to-side anastomosis preferably from within the stomach and boweland within the digestive tract. This procedure may be similar to theRoux-en-Y gastric bypass procedure but with minimal trauma.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows an example of a modified stomach having a smaller pouchcreated from the interior surface lining.

FIG. 1B shows a partial superior view of the cross section from FIG. 1A.

FIG. 2 shows a variation on a marking device or bougie for marking theinterior surface of a stomach.

FIG. 3A shows a variation on positioning a marking device inserted intoa stomach.

FIG. 3B shows a cross section view from FIG. 3A of a deflated stomacharound the marking device.

FIG. 3C shows the cross section view from FIG. 3B of an insufflatedstomach with the resulting marks.

FIG. 4A shows a view of the interior of the lesser curvature of astomach with anchors attached.

FIG. 4B shows a cross section view from FIG. 4A with the anchorsattached.

FIG. 5A shows a side view of a crimping variation on a fastening device.

FIGS. 5B and 5C show a superior and side view, respectively, of severalinterlocked crimping devices from FIG. 5A.

FIG. 6A shows an isometric view of a zip-tie or ratcheted variation on afastening device.

FIG. 6B shows a superior view of the device of FIG. 6A attached to thestomach wall.

FIG. 6C shows a superior view of another double zip-tie variation on afastening device.

FIG. 6D shows the stomach of FIG. 6B with the fasteners cinched.

FIG. 6E shows a superior view of another perpendicular zip-tie variationon a fastening device.

FIGS. 7A and 7B show a superior view of an extendable double hook deviceattaching to a stomach wall.

FIG. 7C shows the device of FIG. 7A locked by a crimping variation.

FIGS. 8A and 8B show a superior view of a modified stomach maintained bya fastening staple.

FIGS. 9A and 9B show isometric views of a variation on an endoscopicstapling device.

FIG. 10 shows an isometric view of a variation on a box stapling device.

FIG. 11A shows an assembly view of another stapling device variation.

FIG. 11B shows a side view of the device of FIG. 11A.

FIG. 12A shows an isometric view of a crescent shaped variation of astapling device.

FIG. 12B shows an end view of the device of FIG. 12A showing a stapledeploying.

FIG. 12C shows an interior side view of the device of FIG. 12A with atranslating wedge sequentially deploying staples.

FIG. 13 shows an interior view of a stomach with an example of staplingdevice placement.

FIG. 14 shows an interior view of a stomach with an example of amodified stapling device which may be used for the treatment of GERD.

FIG. 15A shows an assembly view of a variation on an approximatingdevice.

FIGS. 15B to 15D show the process of invaginating stomach interiorlining and fastening using the device of FIG. 15A.

FIG. 15E shows the assembly view of another variation of the device ofFIG. 15A wherein the clip may be replaced by a screw.

FIGS. 15F to 15H show the process of invaginating stomach interiorlining and fastening using the device of FIG. 15E.

FIG. 16A shows an example of a modified stomach created by a rotatingdevice variation.

FIG. 16B shows a superior cross section view of the stomach of FIG. 16Awhere the modified lumen may be created by rotating the interior stomachlining upon itself.

FIG. 16C shows an alternate superior cross section view of the stomachof FIG. 16A where the modified lumen may be created by rotating apposedportions of the interior stomach lining upon itself.

FIGS. 17A and 17B show an isometric and cross section view,respectively, of a vacuum tube variation.

FIGS. 18A and 18B show an isometric and cross section view,respectively, of a counter-rotating vacuum tube variation.

FIGS. 19A and 19B show an isometric and cross section view,respectively, of a vacuum tube variation with attachment points.

FIGS. 20A and 20B show an isometric and cross section view,respectively, of a split tube variation.

FIG. 21 shows an example of placement within a stomach of a rotatabledevice variation.

FIGS. 22A and 22B show the possible creation of a rotated lumen usingthe device of FIGS. 19A and 19B.

FIGS. 23A to 23D show the possible creation of a rotated lumen using thedevice of FIGS. 20A and 20B.

FIG. 24A shows an isometric view of a variation on a dual rotatable tubedevice.

FIGS. 24B and 24C show an end view and cross section view, respectively,of the device of FIG. 24A.

FIG. 25A shows a variation on an endoscopic vacuum device in a stomach.

FIGS. 25B and 25C show an end view of a variation on lumen creation fromthe interior surface of the stomach using the device of FIG. 25A.

FIG. 26 shows an isometric view of a variation on a gastric volumereduction device.

FIGS. 27A to 27D show the device of FIG. 26 inserted into a stomach todraw or cinch up lining tissue to reduce a volume of the stomach.

FIG. 28 shows another variation on a gastric volume reduction deviceutilizing a grasping device and a ligating device.

FIGS. 29A and 29B show an isometric view on a variation of a gastricvolume reduction device utilizing tractive rollers to draw tissue upbetween them.

FIG. 29C shows another variation of the device of FIGS. 29A and 29B withratcheted rollers.

FIG. 30 shows an isometric view of a variation on a pyloroplasty devicewith an angioplasty balloon.

FIG. 31 shows an isometric view of another variation on a pyloroplastydevice with extendable probes.

FIGS. 32A and 32B show variations on sphincterotome arms for use in apyloroplasty procedure.

FIG. 33 shows a stomach with a distal portion of the wall of the lessercurvature removed to show a possible use for the device of FIG. 31.

FIG. 34A shows an isometric view of another variation on a pyloroplastydevice with a combination cutting and stapling notch.

FIG. 34B shows the device of FIG. 34A in a possible use in a stomach.

FIG. 35 shows a representative and normal gastro-intestinal system of aperson.

FIG. 36 shows an example of a gastro-intestinal system modified by apreferable anastomosis procedure.

FIG. 37 shows an isometric view of a variation on an anastomosisdeployment device.

FIG. 38 shows a cross section view of an anastomosis assembly mating aportion of the stomach with a portion of the intestinal tract.

FIG. 39 shows a cross section view of another anastomosis assemblymating two different portions of the intestinal tract.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

With obesity becoming an increasing problem, various tools and methodsof treatment are described herein which are less traumatic and lessinvasive than procedures currently available. As described in furtherdetail below, a variety of methods for the treatment of obesity, as wellas other gastric-related diseases, are disclosed. Generally, the size ofthe stomach pouch may be reduced to limit the caloric intake as well asto provide an earlier feeling of satiety. This may be accomplished bycreating a smaller gastric pouch within the stomach by a variety ofmethods. This procedure optionally may be enhanced by performing apyloroplasty prior to and/or in conjunction with the pouch sizereduction, i.e., rendering the pyloric sphincter incompetent.Additionally, the food in the stomach may be made to also bypass aproximal portion of the bowel, i.e., a portion of the duodenum andjejunum, by creating a gastric anastomosis thereby creating amalabsorption of sugars and fats which are mostly absorbed in thebypassed portion of the duodenum and jejunum. Sugars and fats enteringthe bowel directly from the stomach rather than passing through thepylorus and proximal duodenum and jejunum may cause “dumping” syndromeand diarrhea. Moreover, rendering the pylorus incompetent may also leadto dumping syndrome partly because of the rapid gastric emptying whichmay occur. This in turn may create enforced behavioral modifications,thereby discouraging the patient from eating these types of high-caloricfoods.

FIG. 1A shows an example of a modified stomach 10 which may be created,by any one of the methods described below, as part of the presentinvention. Greater curvature 12 and lesser curvature 14 is seen inmodified stomach 10, as well as the distal end of esophagus 16 andpylorus 18. As part of the present invention, stomach 10 may be dividedalong junction 24 into modified pouch 22, which is preferably less thanabout 1 ounce in volume, and main pouch 20. FIG. 1B shows a partialsuperior view of the cross section of main pouch 20 and modified pouch22 as viewed from cutting plane P from FIG. 1A. As seen, modified lumen26 is preferably formed by junction 24 from main lumen 28 by joining aportion of stomach wall 30. During ingestion of food, modified pouch 22accepts food from esophagus 16 and preferably passes it directly throughmodified lumen 26 into pylorus 18. Main pouch 20 may remain intact andfunction normally, but preferably sees little or no food. Acids andother fluids that may be generated in main lumen 28 may drain throughthe reduced outlet near pylorus 18 and may pass through the digestivesystem normally.

Marking Tools and Methods

As part of forming a modified pouch, a marking device may be used,preferably at the beginning of the procedure, to create a dye marker“road map” on the interior surface of the stomach from the pylorus tothe esophagus. Once such dye marks are placed, they may be visualized,e.g., endoscopically, thereby giving the physician a clear referencepoint for staple or fixation element placement. An example of such amarking device is shown in FIG. 2 as marking device or bougie 40. Bougie40 is preferably an elongated device made from tubing member 44 whichmay have several channels defined within. Tubing 44 may be made from anyvariety of biocompatible materials, e.g., stainless steel, plastics,etc., and preferably has a diameter and cross section which is similarto that of the finished modified lesser pouch. Along the length may bedefined a series of dye ports 46 through which the marking dye may bechanneled through from the proximal end of bougie 40. Any variety ofbiocompatible dyes which preferably enhance visualization may be used,e.g., methylene blue, thionine, acridine orange, acridine yellow,acriflavine, quinacrine and its derivatives, brilliant green, gentianviolet, crystal violet, triphenyl methane, bis naphthalene, trypan blue,and trypan red. Also along the length and on either side of dye ports 46may be a series of vacuum ports 48, which are optional. A distal balloon52, which may be inserted into the pylorus to stabilize bougie 40 duringthe procedure, is preferably attached to inflation tip 50 at distal end42 and may be inflated from the proximal end of tubing 44 by thephysician.

FIGS. 3A to 3C show bougie 40 during one method of use. FIG. 3A showsstomach 60 as bougie 40 is inserted down through esophagus 62. As bougie40 is advanced down to pylorus 76, distal balloon 52 may be inflatedthrough inflation tip 50, thus securing the device. Bougie 40 preferablyfollows lesser curvature 64 and may alternatively be shaped toapproximate lesser curvature 64. Bougie 40 is also preferably rotatedsuch that dye ports 46 face away from lesser curvature 64 and facetowards greater curvature 66. Then the air and fluids contained withinstomach 60 are preferably removed, either through vacuum ports 48, ifthey are included in bougie 40, or through another vacuum port which maybe introduced endoscopically through esophagus 62. FIG. 3B shows crosssection 3B-3B from FIG. 3A as deflated stomach 60. Once deflated,modified lumen 70 may take shape around bougie 40, separate fromdeflated main lumen 68. In this deflated state, the dye may be channeledthrough dye ports 46, thereby leaving dye marks 72 on interior lining74. Once the staining has been performed, lumen 68 may be insufflated,as shown in FIG. 3C, and bougie 40 may then be removed. As seen in FIG.3C, dye marks 72 mark or delineate the junction region where anchors orfasteners may be placed to draw interior lining 74 together to form themodified lumen.

Gastric Reduction Tools and Methods Using Fasteners

One variation of reducing the stomach size involves grasping theinterior walls of the stomach, preferably via an endoscope advancedtransesophageally, and placing one to several fixation elements onopposing interior walls and then bringing those fixation elementstogether.

Several examples of different possible variations on fasteners are shownand described below. These variations are not intended to be limitingbut are merely given as illustrative examples.

FIG. 4A shows a view of the interior of the lesser curvature of stomach60 with part of the greater curvature wall removed. As seen, individualanchors 80 may be secured to the interior surface along the junction 24where modified pouch 22 from FIG. 1A would form. Anchors 80 may be ofany biocompatible material, e.g., stainless steel, polymers, etc., whichmay be formed into a variety of fasteners, e.g., staples, ratchetedwires, zip ties, clips, tags, eyelets, crimps, and screws. Anchors 80may be placed by estimating the junction boundary, but they arepreferably located along dye mark 72, which may be formed by methods andtools described above, prior to anchor 80 placement, as shown in FIG.4B, which is cross section 4B-4B from FIG. 4A. After anchors 80 havebeen fastened, suture 82 may be drawn through each of the anchors 80,preferably in a zig-zag manner, and then suture 82 may be drawn tight tobring the opposing surfaces of interior lining 74 together in appositionalong dye marks 72 to form the modified lumen. Alternatively, individualanchors 80 may be preloaded or prefastened by suture 82, and anchors 80may be fastened to interior lining 74 in this manner.

FIG. 5A shows a side view of a variation on a fastening device incrimping member 90. Crimping member 90 is preferably made from abiocompatible material, e.g., stainless steel, nitinol, etc., and may beformed to have elbow 92 extend into two opposing anchoring ends 94. FIG.5B shows a superior view of a created modified lumen 100 formed frommain lumen 98 by any of the methods described herein. In this variation,several crimping members 90 may be attached or fastened to interiorlining 96 by anchoring ends 94. As they become attached, each of themembers 90 are preferably configured to interlock with an adjacentcrimping member 90, much like a zipper. FIG. 5B shows the interlockedmembers 90 from the top to form lumen 100 and FIG. 5C shows the viewfrom 5C-5C from FIG. 5B where each of the crimping members 90 are showninterlocking at their elbows 92 like a zipper.

FIG. 6A shows an isometric view of another variation on a fasteningdevice in ratcheted wire or zip tie 110. This particular variation showsa distal tip or male end 112 and a corresponding proximal end or femaleend 114, with ratcheted length 116 between those two ends. FIG. 6B showsa superior view of stomach wall 120 just prior to the formation ofmodified lumen 124 from main lumen 122. As seen, male end 112 of firstzip tie 110′ maybe pierced through one side of interior lining 118 andsecond zip tie 110″ may be pierced through the opposing side of interiorlining 118 such that the male ends 112 of each zip tie preferablycorrespond to the female ends 114 of the other zip tie. To then form thelumen 124, each zip tie 110′, 110″ may be drawn together and tightenedaccordingly, as shown in FIG. 6D. A plurality of zip ties 110 arepreferably used to form modified lumen 124 by aligning them by any ofthe methods described above.

An alternative zip tie device which may be used is a perpendicular typeversion of zip tie 110. As shown in FIG. 6E, first perpendicular zip tie134′ and second perpendicular zip tie 134″ may be used in place of ziptie 110 and lumen 124 may be formed in much the same manner as describedabove to result in the modified stomach as shown in FIG. 6E. A furtheralternative is shown in FIG. 6C where male zip tie 126 preferably hasdual piercing male ends with catcher tubes 128. In this variation, avacuum-type device, as described below in detail, or forceps may be usedto draw portions of stomach wall 120 in apposition. As the apposedstomach walls 120 are positioned, needles 130, which are preferablypassed through a double female zip tip 132, may be used to piercethrough tissue 120 and lock into catcher tubes 128. Needles 130 may thenbe drawn back through tissue 120, while simultaneously pulling maleends/catcher tubes 128 back through tissue 120 and into thecorresponding double female zip tie 132. The locked zip tie 126 may thenbe drawn tight against female zip tie 132, trimmed, and then released.This procedure may be repeated for any number of zip ties which may beused to draw the stomach lining together to form the smaller pouch andmay also be used with the dye marking device 40 and procedure asdescribed above.

A further variation on the individual anchoring fasteners is shown inFIG. 7A. This variation shows gasping device 140 with retaining tube 142and extendable members 146 which may extend from distal opening 144.Extendable members 146 are preferably made from a biocompatiblematerial, e.g., superelastic or shape memory alloy such as nitinol,which may be biased to urge away from a longitudinal axis defined bytube 142 once extended beyond distal opening 144. As members 146 extend,they may reach out to grasp apposed portions of interior lining 150 byhooks 148. As above, the locations where hooks 148 grasp may be definedby the marking device as described above and viewed by the physicianthrough, e.g., an endoscope. Once hooks 148 have grasped the appropriateportion of lining 150, members 146 may then be drawn back through distalopening 144, as shown in FIG. 7B, and a retaining device, such as crimp152, may be slid over a distal section of members 146, as shown in FIG.7C, to maintain the position of hooks 148 and apposed lining 150 tocreate the desired lumen.

Gastric Reduction Tools and Methods Using Stapling Devices

Aside from individual anchoring and fastening devices, the stomach pouchmay be modified and/or created by a variety of other device variationsutilizing other methods. FIG. 8A shows the cross sectioned superior viewof FIG. 1B with the addition of staple 160 maintaining junction 24. Thefigure shows an example of how, e.g., an endoscopically applied stapler,may be used to retain and hold junction 24 to form modified lumen 26.FIG. 8B shows a close-up view of the junction 24 and staple 160 whichwas applied from within lumen 26.

To staple opposing sides of a stomach together to form two separatelumens from within the interior surface of the stomach, an endoscopicstapling device may be used to accomplish such a task. Such anendoscopic stapler preferably brings two regions of tissue intoapposition and may then apply a fastening element, e.g., staples, clips,tags, etc., into the two regions of tissue to affix them together. Thesestapling devices may optionally incorporate the use of the markingdevice or bougie 40, as described above, as a preliminary step as aguide to vacuum placement and/or stapling to form the desired modifiedlumen. The fastening elements, e.g., staples, are preferably made of abiocompatible material such as stainless steel, titanium, polymers,sutures, nitinol, or any other similar metals and alloys, etc. and maybe in any conventional shape such as C-shaped and U-shaped staples orany of the other shapes as described herein. The two regions of tissuemay be adhered to the stapling device by a variety of attachmentmethods, e.g., tines, barbs, hooks, vacuum, or any combinations thereof.In an adhering device utilizing a vacuum to hold the apposing regions oftissue together, such a device may be a tubular or wand-shaped memberand preferably has at least two windows which may be spaced about thecircumference of the tube or wand. These windows may be separated by anarc in a range of about 20° to 180° about the longitudinal axis definedby the length of the tube or wand, and are preferably separated by anarc in a range of about 90° to 180°.

Several examples of different possible variations on the stapling deviceare shown and described below. These variations are not intended to belimiting but are merely given as illustrative examples.

FIG. 9A shows a variation of an endoscopic stapling device in theisometric view of anvil stapling device 170. Stapling unit 172 is shownattached to the distal end of tube 174. Within stapling unit 172 isstaple enclosure 176 where staples may be loaded and vacuum ports 178which are seen in an alternating fashion with staple slots 180, throughwhich the staples may be deployed. FIG. 9B shows a reverse isometricview of the device of FIG. 9A. As seen, stapling unit 172 may haveseptum 184 insertable into septum slot 186, which is preferably midwaybetween the sides of staple enclosure 176 and which may separate theinterior of staple enclosure 176 into two separate chambers. Septum 184may serve several functions, one of which may be to allow selectiveactivation of opposing sides of vacuum ports 178 of unit 172 as tissueis selectively adhered to the device. Other functions of septum 184 arediscussed below.

In operation, stapling unit 172 may be inserted trans-esophageally intoa stomach and a first portion of the interior lining may be adhered to asingle side of staple enclosure 176 through a vacuum created withinvacuum ports 178. The vacuum may be created in stapling unit 172 throughtube 174 and activated from the proximal end of tube 174 from outsidethe patient's body. Once the first portion of the interior lining isadhered to one side of staple enclosure 176, the opposite set of vacuumports 178 may be activated and unit 172 may be used to draw the firstportion to an opposing second portion of the interior lining, which maythen be adhered to the device such that the first portion and the secondportion are preferably in apposition to each other. This actionpreferably forms the modified lumen 26 of FIGS. 8A and 8B. As the tissueis held to unit 172, septum 184 may be withdrawn from septum slot 186 byintroduced forceps through, e.g., an endoscopic or through an integralactuator, to form a single chamber within staple enclosure 176. Removalof septum 184 may then bring the first and second portions of tissueinto contact apposition. The side surfaces 188 of septum 184 mayincorporate a cutting, abrading, scoring, heating, freezing, chemicallydamaging, or some other damaging surface to tissue. Such a surface 188may damage the interior lining contacting each other upon removal ofseptum 184 as surface 188 slides past. This damage may encourage a morevigorous healing response and a more permanent fixation between thedamaged tissue once stapled or affixed together.

After removal of septum 184, the staples loaded within staple enclosure176 may be fired through staple slots 180 to affix the tissue. As thestaples are fired, anvil 182 may be used as an anvil to secure thestaples to the tissue, thereby resulting in the modified lumen 26 asshown in FIG. 8B. The length of stapling device 170 may be madeaccording to the desired junction length and the size of the patient'sstomach. This particular variation may be withdrawn from the area afterthe stapling procedure by first pushing the stapling device 170 past theresulting staple line.

FIG. 10 shows an isometric view of another variation in box staplingdevice 190. Stapling unit 192 is shown as being attached in fluidcommunication to vacuum tube 193. Stapling device 190 may be insertedand operated in the same manner as device 170 described above. Staplingunit 192 may have vacuum ports 194 activated selectively on either sideof septum 196 as described above. The tips of staples 198 are shownpartially deployed for illustration purposes, but are preferably notdeployed until septum 196 is first retracted preferably in the directionas indicated. Septum 196 may also be configured to damage the contactingtissue upon septum 196 withdrawal in the same manner as described above.Stapling device 190 may be easily applied and removed after staples 198have been deployed.

FIG. 11A shows an assembly isometric view of another variation instapling device 200. This variation 200 shows curved tube 202 which mayhave lumen 204 house staples 206 as well as act as a combination vacuumand staple slot 216. Tube 202 may be shaped in a variety of ways but isshown here as a C-shaped or U-shaped tube with first channel 210′ andsecond channel 210″, for adhering the two apposed portions of tissue,preferably separated by removable septum 212. With this variation 200,tissue may be adhered within the channels 210′, 210″ throughvacuum/staple slot 216 and once positioned, staples 206 may be deployedwhile septum 212 is removed simultaneously by the use of curved wedge218. In operation, curved wedge 218 may be drawn within lumen 204 fromthe tube 202 distal end to the proximal end by, e.g., a pull-wireattached to wedge 218. As wedge 218 is advanced proximally, wedge 218would preferably force pivot 208 of staple 206 against contact edge 214of septum 212. As wedge 218 is advanced further proximally, urging end220 may then urge the curved ends of staple 206 to rotate about pivot208 and deploy through slot 216. While staple 206 is deploying, notch222, preferably located at a distal end of wedge 218, may engage contactedge 214 and begin to slide septum 212 simultaneously towards theproximal end of tube 202. FIG. 11B shows a side view of stapling device200 of FIG. 11A. As seen, curved wedge 218 preferably contacts septum212 via notch 222 and pushes while simultaneously urging staple 206 todeploy. The figures show a single staple 206 for illustrative purposesonly and any plurality of staples 206 may be used in practice dependingupon the desired results.

FIG. 12A shows an isometric view of yet another variation in staplingdevice 230. This variation may omit a removable septum. Curved tube 232is preferably curved in this variation in a crescent shape formingcontact channel 234. Within contact channel 234, a number of vacuumports 236 and staple slots 238 may be defined in an alternating pattern,as shown. A possible W-shaped staple 240 preferably having pivot 242 atthe staple 240 midpoint is shown outside of tube 232 for illustrativepurposes in a possible orientation for insertion within staple slots238. FIG. 12B shows cross section 12B-12B from FIG. 12A. As seen, tube232 defines lumen 244, which preferably runs the length of tube 232, andtranslating wedge 246 which is preferably slidingly disposed withinlumen 244. As seen in FIGS. 12B and 12C, which is a side view of theinterior of tube 232, wedge 246 may be translated by pull-wire 248.Pull-wire 248, which may be made of any high-strength material, e.g.,stainless steel, nitinol, nylon, polymers, etc., may be manipulated by aphysician from the proximal end of tube 232 from outside of thepatient's body. Like the device 200 of FIGS. 11A and 11B, once vacuumports 236 have acquired the interior tissue lining to be approximated,translating wedge 246 may be advanced proximally. Advancing wedge 246may urge staples 240 to deploy through staple slots 238 sequentially asshown to hold the tissue and form the desired lumen.

An example of deployment for any of the stapling devices described aboveis shown in FIG. 13. As shown, stomach 250 with the wall partially cutout is seen with stapling device 252 inserted within. Stapling device252 is shown merely as an example of insertion and could comprise any ofthe devices described herein. Device 252, which is preferably advancedtransorally into stomach 250 and through esophagus 256, is preferablylocated at the distal end of delivery/vacuum tube 254. Once inserted,device 252 may be located by the assistance of the lesser curvature 258of stomach 250. Also shown are vacuum/staple ports 260, which may be anyof the configurations as described herein. In a preferable variation,stapling device 252 may be configured to produce a staple line orjunction following the lesser curvature beginning from cardiac notch 264down towards pylorus 262. Accordingly, device 252 may have the lengthand vacuum/staple ports 260 configured such that the distal end ofdevice 252 points towards pylorus 262.

FIG. 14 shows stapling device 270 in a slightly different configurationfor the treatment of other gastro-intestinal diseases such asgastroesophageal reflux disease (GERD), as discussed above. The stomach250 of FIG. 13 is shown, but for the treatment of GERD, stapling device270 may be slightly modified such that the device 270 and vacuum/stapleports 272 may be straight or flared away from, rather than towards,lesser curvature 258 and pylorus 262 as described above. As such,vacuum/staple ports 272 would preferably produce a staple line orjunction beginning from cardiac notch 264 and then flares away fromlesser curvature 258 and pylorus 262. Device 270 may be any of thedevices described and operated herein, but for the flared modification.Likewise, any of the devices described herein may be used for thetreatment of GERD by simply angling the device to produce a flaredstaple line. Alternatively, a simple non-flared staple line may alsosuffice for treating GERD. The staple line may act as a Heimlich valvewhich preferably closes down in response to pressure exerted from thegreater or main lumen. Moreover, the smaller volume of the modifiedlumen in-line with esophagus 256 may provide a smaller volume of acidavailable for esophageal reflux.

An isometric view of a single channel vacuum device variation is shownin FIG. 15A in approximating device 280. Tube 282 is preferably atubular device which may be inserted into a stomach through theesophagus of a patient. A lumen 284 may run through tube 282 from aproximal end to the distal end of tube 282. At the distal end, two ormore windows or slots 286 are preferably defined opposite of oneanother, as shown. The lengths and widths of slots 286 may vary and ispreferably long enough to approximate the desired length of the boundaryor junction line of the modified lumen; likewise, the width ispreferably wide enough to accommodate at least two layers of the stomachinterior lining. Approximating clip 288 is shown having at least twopiercing ends 290 and may be loaded into tube lumen 284 from either theproximal end or distal end of tube 282 preferably prior to inserting thedevice 280 into the patient. Clip 288 is preferably made of abiocompatible material as described above. Biodegradable plug 292 may beplaced into the distal end of tube 282 prior to insertion into thepatient and is preferably made of a biocompatible biodegradablematerial, e.g., biodegradable polymers such as polylactide,polyglycolide, and their copolymers. Plug 292 may be alternatively madefrom a non-biodegradable material and may simply pass after theprocedure. Plug 292 may aid in maintaining a vacuum seal through slots286 during the approximation procedure, as described below.

FIG. 15B shows an end view from section 15B-15B from FIG. 15A of tube282 in operation. As shown, opposing portions of stomach interior lining294 may be drawn into lumen 284 through opposing slots 286 by creating avacuum within lumen 284. Approximating clip 288 may be urged distallythrough tube 282 such that each of ends 290 may be drawn through acorresponding slot 286 over and/or pierced through lining 294 withinlumen 284. As lining 294 is approximated within lumen 284, biodegradableplug 292 may become invaginated within lining 294. Accordingly, as clip288 and ends 290 are positioned over lining 294, tube 282 may bewithdrawn from the area while clip 288 preferably slides through thedistal end of tube 282 leaving the approximated interior lining 294 heldin position by ends 290, as seen in FIG. 15D. Removal of tube 282 mayurge plug 292 to slide off the distal end of tube 282 and remain withinthe newly formed lumen to become degraded over time or to pass throughthe patient's system.

FIG. 15E shows the device of FIG. 15A, but in this variation, clip 288may be replaced by screw 289, which is preferably in the shape of ahelix or coil having a tapering width or diameter. The first few turnsor coils of screw 289 may have the same or similar diameter than theremaining tapering coils; this may enable piercing end 291 to engageinterior 294 and may also allow screw 289 to be advanced at the desiredorientation through the tissue. Screw 289 preferably maintains aparallel orientation with tube 282 during delivery into the tissue,i.e., a longitudinal axis defined by screw 289 is preferably parallel,or close to parallel, with the longitudinal axis defined by tube 282.Moreover, the outer diameter of the first few turns or coils arepreferably the same diameter, or slightly less than, the inner diameterof tube 282. This may further enable screw 289 to be advanced throughlumen 284 at the proper orientation prior to engaging interior 294.

As described above for the device of FIGS. 15A to 15D, opposing portionsof stomach interior lining 294 may be drawn into lumen 284 throughopposing slots 286 by creating a vacuum within lumen 284, as shown inFIG. 15F. Screw 289 may then be urged through lumen 284 and rotated inthe direction of the arrow shown until piercing end 291 engages theinvaginated lining 294. Piercing end 291 preferably is sharp andneedle-like to enable piercing through multiple layers of lining 294. Asscrew 289 is further rotated, it may be further advanced distallythrough the remaining portion of invaginated lining 294. The taperingdiameter and decreasing width may also begin to further approximate theopposing edges of lining 294 towards one another, as shown in FIG. 15G.Finally, as seen in FIG. 15H, further advancement of screw 289preferably draws the opposing surfaces into contact with one another.Tube 282 may then be removed, as described above. Although the fixationof one screw 289 is described, multiple screws 289 may be fastened oneafter another to form a continuous fixation line.

Screw 289 may be made of a bioabsorbable or biocompatible material, asdescribed herein such as a polymer or superelastic alloy, and may beintegrally formed with barbs or whisker-like filaments protruding alongits length to help prevent screw 289 from backing out once it has beenengaged within the lining 294. An example of a spiraling suturing needleor screw which may be used in this variation is shown and described inU.S. Pat. No. 5,330,503 to Yoon, which is incorporated herein byreference in its entirety. Another example of a helical fastener orscrew and applicator which may be used in this or another variation isshown and described in U.S. Pat. No. 5,582,616 to Bolduc et al., whichis also incorporated herein by reference in its entirety. Other examplesof helical fasteners or screws and applicators are also shown in U.S.Pat. No. 5,810,882; U.S. Pat. No. 5,824,008; and U.S. Pat. No.5,964,772; all to Bolduc et al., each of which is incorporated herein byreference in their entirety.

Gastric Reduction Tools and Methods Using Rotatable Devices

Aside from endoscopically applied stapling and clip devices, rotatingand rotatable probes may also be used to form a modified smaller lumenwithin a main lumen. Such probes generally may be inserted into astomach endoscopically and may engage a portion of the interior liningof the stomach and may then be rotated to roll the engaged portion ofthe stomach wall around the probe itself to bring the wall in appositionwith another portion of the stomach wall. Such rotating probes may beused to create a blind-ended pouch of stomach within the main stomachlumen, or as with the other devices, may be used to create a smallerpouch exiting into the pylorus. Once the roll of stomach wall is broughtinto apposition, a row or a plurality of fasteners, e.g., staples, blindstaples, clips, tags, adhesives, etc., may be used to maintain thestomach. The tubes themselves may be made of any variety ofbiocompatible materials which preferably have sufficient strength toundergo a torsional load, e.g., stainless steel, nickel, platinum, etc.

An example of a stomach modified by such a rotating probe or device isshown in FIG. 16A. Main pouch 300 is seen with modified pouch 302 formedalong the lesser curvature of the stomach and delineated by junction304. This example shows modified pouch 302 extending from esophagus 306and terminating in pouch opening 308 proximally of pylorus 310. Pouchopening 308 may also be made to terminate at pylorus 310.

FIG. 16B shows a superior view from cross section 16B-16B from FIG. 16Aof one variation on producing modified pouch 302 having modified lumen314 from main pouch 300 having main lumen 312 where junction 304 may beformed by rotating the stomach upon itself. FIG. 16C shows analternative superior view from cross section 16B-16B from FIG. 16A wheremodified pouch 302′ having modified lumen 314′ may be formed from mainpouch 300′ having main lumen 312′. In this particular variation,junction 304′ may be formed by taking apposed sides of the interiorstomach lining near the lesser curvature and approximating them to formmodified lumen 314′.

Several examples of different possible variations on the rotating probeor device are shown and described below. These variations are notintended to be limiting but are merely given as illustrative examples.

FIG. 17A shows vacuum tube 320 which may have an elongate tubular body.Tube 320 may be inserted into a patient's stomach transesophageally via,e.g., an endoscope. Accordingly, distal end 322 is preferably rounded orgently tapered to be atraumatic to the patient. An opening or window 324may be defined in the wall of tube 320 near distal end 322 and as seenin FIG. 17B, opening 324 is preferably in communication with lumen 326,which may run throughout tube 320. The geometry of opening 324 ispreferably large enough to accommodate the invagination of tissue fromthe interior stomach lining by a vacuum created within lumen 326 andopening 324. The vacuum may be activated by the physician from aproximal end of tube 320 from outside of the patient. Once tissue isinvaginated within window 324, a fastening member may be inserted anddeployed to secure the interior stomach lining thereby reducing itsoverall volume, as described in further detail below. As shown in FIG.17B, which is cross section 17B-17B from FIG. 17A, tube 320 preferablyhas a diameter and cross section which may approximate a final geometryof the newly created lumen within the stomach.

FIG. 18A shows an isometric view of another variation incounter-rotating tube 330. Counter-rotating tube 330 may have a gentlytapered distal end 332 with an opening 334 defined in the tube wall neardistal end 332. Preferably contained within tube 330 is an additionalinner tube 336, which may be geometrically similar to tube 330 but witha diameter small enough to allow free rotation about the longitudinalaxis preferably shared by both tubes 330 and 336. Inner tube 336likewise may have inner opening 338, which may allow communicationbetween lumen 340 and openings 334 and 338. As above, a vacuum may beactivated from a proximal end of tube 330 to draw tissue from theinterior stomach lining through lumen 340 and into openings 334 and 338when they are aligned. As shown in FIG. 18B, which is cross section18B-18B from FIG. 18A, once the tissue has become invaginated withinopenings 334, 338, inner tube 336 may be rotated to effectively pinchand firmly hold the tissue in place, as shown in FIG. 18B. The additionof the pinching action in addition to the vacuum may aid in holding thetissue, thereby aiding in the rotation of both tube 330 and inner tube336 when forming the modified lumen. Both tubes 330 and 336 may bemanipulated and rotated from a proximal end of the tubes from outside ofthe patient.

FIG. 19A shows an isometric view of another variation in barbed tube350. Tube 350 may be similar to vacuum tube 320 described above. Distalend 352 is preferably tapered and opening 354 may be defined in the wallof tube 350 near distal end 352. Additionally, at least one andpreferably several attachment points 356, e.g., tines, barbs, or hooks,may be defined along at least a single edge around opening 354.Attachment points 356 are preferably defined along the leading edge ofopening 354 for rotation of tube 350. FIG. 19B, which is cross section19B-19B from FIG. 19A, shows opening 354 preferably in communicationwith lumen 358 and a preferred orientation of attachment point 356.

FIG. 20A shows an isometric view of yet another variation in split tube360. Split tube 360 may be formed of at least two splittable halves,e.g., first half 364 and second half 366, which may be joined togetherlongitudinally along split 370. When first half 364 and second half 366are joined together, split tube 360 preferably forms a tapered distalend 362. Split tube 360 may also define a lumen 372 which may runthroughout the length of split tube 360. This variation may alsocomprise at least one and preferably several attachment points 368 oneach of first half 364 and second half 366. As shown in the figure,first half 364 may have a row of attachment points 368 preferablyaligned along a portion of split 370 and second half 366 may likewisehave a row of attachment points 368 juxtaposed and preferably mirroringthose located on first half 364. Attachment points 368 may be of anytype described above and the number and positioning of attachment points368 may depend upon the desired length of the resulting junction formedupon rolling the stomach. FIG. 20B, which is cross section 20B-20B fromFIG. 20A, shows split 370 and an example of the juxtaposed relationshipof attachment points 368.

FIG. 21 shows an example of a rotatable probe device during insertioninto stomach 380. As seen, tube 384 may be inserted into stomach 380 viaesophagus 382, preferably endoscopically. Tube 384 may be any of thedevices described above and is shown generally as an example of how suchdevices may be inserted into an organ, e.g., stomach 380. As tube 384 isinserted, it may engage a portion of the interior of stomach 380,preferably along lesser curvature 386. The engagement may beaccomplished by any of the methods described herein, e.g., attachmentpoints partially piercing the stomach lining, a vacuum adhering aportion of the lining, etc. Once engaged, tube 384 may then be rotatedto roll the engaged portion of the stomach wall around the probe itselfto bring the wall in apposition with another portion of the stomachwall.

FIG. 22A shows a variation on partial cross section 22/23-22/23 fromFIG. 21 with tube 350 from FIGS. 19A and 19B in a preferred operation.As shown, interior lining 390 may be adhered to tube 350 via a vacuumcreated in opening 354 through lumen 358 and/or via attachment points356 which may partially pierce lining 390, as described above. Thelocation for adhering tube 350 may also be determined or aided by theuse of marking device 40, as described above. Once the desired locationof interior lining 390 has been established, tube 350 may be rotatedabout its longitudinal axis, following the arrow as shown, by at leastabout 180° and preferably at least about 360°. Lining 390 is preferablyrotated until the adhered portion contacts a second portion of lining390 to result in the modified lumen 314 of FIG. 22B, also shown in FIG.16B. Once modified lumen 314 has been formed, fasteners may be fired ordeployed through opening 354 or via a separate endoscopic staplingdevice at location 392 to secure and maintain modified lumen 314.Fasteners may comprise any of the fasteners as described herein, e.g.,staples. Once modified lumen 314 has been secured, tube 350 may then beremoved. FIG. 16B shows newly created modified pouch 302 with modifiedlumen 314 and, as seen, interior lining 390 also forms the interiorsurface defining modified lumen 314.

FIGS. 23A to 23D show another variation on partial cross section22/23-22/23 from FIG. 21 with split tube 360 from FIGS. 20A and 20B.Split tube 360 may be inserted into the stomach either as separatehalves 364, 366 individually or as a whole tube which may then be splitwhile in the stomach. Once separated, first half 364 and second half 366may be engaged to interior lining 390 by attachment points 368 at aslight distance from one another. The separation distance may bedetermined by the desired resulting size of the lumen. Alternatively,the separation distance may be determined or aided by the use of markingdevice 40, as described above.

Once first half 364 and second half 366 have engaged interior lining390, as shown in FIG. 23A, each of free ends 394 of halves 364, 366 maythen be rotated in the direction of the arrow, as shown. Free ends 394may be configured to simply contact each other or to interlock with eachother and rotate about a hinge or pivot. As first half 364 and secondhalf 366 continue to be rotated, FIGS. 23B and 23C show the progressionof lumen formation as attachment points 368 draw around and towards oneanother. Finally in FIG. 23D, as split tube 360 is preferably formedagain, modified lumen 314′ may be formed, as also shown in FIG. 16C, tothen be secured or maintained preferably by fasteners, e.g., staples,which may be deployed through junction 304′.

A further variation on a rotating device is shown in the isometric viewof dual tube device 400 shown in FIG. 24A. Dual tube device 400 may haveat least two elongate members, first member 402 and second member 404,which may be rotatingly attached to controlling device 406 and may beparallel to each other. The members 402, 404 are preferablycounter-rotating and may be rotated by a rotation control 408, which ispreferably located on controlling device 406. First member 402 may havefirst distal end 410 offset slightly from the longitudinal axis of firstmember 402 by first bend 412. First opening 414 is also preferablydefined in the wall of first member 402 proximally of first distal end410. Second member 404 is preferably similar to first member 402 and mayhave second distal end 416 offset slightly from the longitudinal axis ofsecond member 404 by second bend 418. Near second distal end 416, secondopening 420 may be defined in the wall of second member 404.

FIG. 24B shows end view 24B-24B from FIG. 24A. Distal ends 410, 416 areseen as preferably being parallel and mirror images of one another.Also, the preferable counter-rotating action may be seen by thedirectional arrows. FIG. 24C shows cross section 24C-24C from FIG. 24A.As shown, the relationship between first and second opening 414, 420,respectively, and first and second lumen 422, 424, respectively, may beseen in the figure. Lumens 422, 424 preferably run through the length ofmembers 402, 404, respectively, and are in communication with openings414, 420. A vacuum may be created in openings 414, 420 through lumens422, 424, respectively, from the controlling device 406. In operation,members 402, 404 may be inserted trans-esophageally into a patient'sstomach. A vacuum may then be created in first and second openings 414,420 to engage a portion of the stomach interior lining. Once engaged, amodified pouch may be created from the interior lining in much the samemanner as described for FIGS. 23A to 23D, except the individualcounter-rotating members 402, 404 do not form a split tube. Theoperation of the vacuum application and counter-rotation may becontrolled through controlling device 406 which is preferably locatedoutside the patient's body.

FIG. 25A shows yet another variation in vacuum device 432 shown insertedinto stomach 430. Vacuum device 432 may be an endoscopic device insertedtrans-esophageally into stomach 430 through esophagus 434. Device 432may have vacuum member 438 and at least two grasping members 440,preferably disposed on either side of vacuum member 438. Once device 432has been introduced into stomach 430, vacuum member 438 may be steeredtowards a desired area of interior lining 442, as seen in FIG. 25B whichis a cross section view of device 432 attached to stomach interiorlining 442. The desirable area of interior lining 442 may be locatedalong greater curvature 436 or alternatively along lesser curvature 444,depending upon the desired results. In position, a vacuum may beactivated in member 438 to draw a portion of interior lining 442preferably between grasping members 440. As lining 442 is adhered tovacuum member 438, grasping members 440 may be used to pinch and graspthe drawn portion of lining 442. Then, device 432 may be rotated in thedirection of the arrow indicated in FIG. 25C to result in the formationof a modified lumen. Afterwards, grasping members 440 may be locked inplace, disengaged from device 432, and left as an implant.Alternatively, lining 442 may be fastened to maintain the created lumenby any of the methods described herein and grasping members 440, alongwith the rest of device 432, may be removed from stomach 430.

Gastric Reduction Tools and Methods Using Volume Reduction Devices

Aside from the use of rotating and rotatable probes, gastric volumereduction devices may also be used as part of the present invention.Such volume reduction devices generally may be inserted into a stomachtrans-esophageally through the use of, e.g., an endoscope. The reductiondevice may be used to draw or engage a portion of the interior lining ofthe stomach; the drawn or engaged portion may then be eventuallyremoved, either actively or through natural processes.

Several examples of different possible variations on the gastric volumereduction devices are shown and described below. These variations arenot intended to be limiting but are merely given as illustrativeexamples.

FIG. 26 shows an isometric view of a variation on the gastric volumereduction device in concentric tube device 450. Device 450 may haveinner tube 452 defining lumen 454, which preferably runs throughoutinner tube 452. Pusher sleeve 456 may be disposed concentrically overinner tube 452 such that pusher sleeve 456 may be allowed to slidefreely along inner tube 452. Pusher sleeve 456 is also preferablydisposed over inner tube 452 such that the distal end of inner tube 452is open to allow ring 458 to be rolled or stretched onto the distal end.Ring 458 is preferably made of an elastic type material which wouldallow ring 458 to elastically cinch onto inner tube 452.

During use, FIG. 27A shows a view of concentric tube device 450 withinstomach 460 preferably inserted through esophagus 462. The distal end ofdevice 450, particularly inner tube 452, may be brought into positionnear a location of interior surface 464 where tissue may be desirablyremoved. As shown in FIG. 27B, once device 450 is in place, a vacuum maybe actuated within lumen 454. The vacuum may then draw a portion ofwithdrawn lining tissue 466 up into lumen 454, as seen in the crosssection of device 450. While lining tissue 466 is held within lumen 454,pusher sleeve 456 may be pushed or urged distally along inner tube 452.As pusher sleeve 456 advances, it may also push or urge elastic ring 458distally along inner tube 452 until ring 458 is pushed entirely off thedistal end of inner tube 452 and onto a portion of lining tissue 466, asseen in FIG. 27C. Device 450 may then be removed from stomach 460 afterceasing the vacuum, thereby leaving lining tissue 466 with elastic ring458. After time, as seen in FIG. 27D, pressure necrosis may cause liningtissue 466 and ring 458 to simply fall off from the rest of interiorsurface 464 to be passed normally through the rest of the patient'sbody. The action of drawing up and removing a portion of interiorsurface 464 may effectively reduce the overall volume of stomach 460,thereby reducing the available volume for the ingestion of foods. Assuch, this procedure may be repeated several times either sequentiallyor simultaneously until the overall volume of stomach 460 is reduced toa desirable volume depending upon the desired results.

FIG. 28 shows another variation on the gastric volume reduction device.As shown, an endoscope 474 preferably having grasping device 476, e.g.,biopsy forceps, may be inserted into stomach 472. A ligating apparatus,e.g., ring stapler, zip tie, etc., either as part of endoscope 474 or asa separately introduced ligation device 478, is preferably alsointroduced within stomach 472. Forceps 476 and ligation device 478 maybe used in conjunction with one another by, e.g., having forceps 476grasp withdrawn tissue 480 and then having ligation device 478 tie orligate tissue 480. Forceps 476 may then be used to excise and removewithdrawn tissue 480 above ties 482 to reduce the overall stomachvolume. An example of a jaw structure which may be utilized is shown anddescribed in U.S. Pat. No. 5,749,893 to Vidal et al., which isincorporated herein by reference in its entirety. Alternatively, ligatedwithdrawn tissue 480 may be left attached to stomach 470 to be removednaturally by pressure necrosis. Several excisions may be performed inreducing stomach volume from, e.g., stomach 472 (as shown by the dashedlines) down to a final reduced stomach 470.

FIG. 29A shows yet another variation with tractive rollers 490. Thisdevice may have at least two rigid rollers 492, which are preferablyelongated, connected to one another preferably at both ends by, e.g.,elastic members 494. The connection of rollers 492 may create channel496 therebetween through which tissue may be drawn. FIG. 29B showsrollers 492 with a portion of stomach interior surface 498 being drawnthrough channel 496 by a grasping device, e.g., forceps 500. Meanwhile,rollers 492 may be maintained within the stomach by, e.g., retainingforceps 502, which may be used to hold rollers 492 relative to interiorsurface 498. Elastic members 494 may pinch rollers 492 together, therebycreating a zone of pressure necrosis in withdrawn interior surface 498.Also, as interior surface 498 is drawn up through channel 496, rollers492 may contain a ratcheting device within to prevent surface 498 fromrolling out back through channel 496. Once the desired amount of surface498 has been drawn, it may either be excised or simply left to beremoved naturally by necrosis. FIG. 29C shows an alternative variationwith ratcheted rollers 504. Ratcheted rollers 504 may be operated in thesame manner as described for rollers 492 but they preferably have atractive surface to enhance traction between the tissue and the rollers504. Torquing device 506 may be used with ratcheted rollers 504 and maybe introduced into the stomach endoscopically to mesh with one ofrollers 504 for the purpose of causing it to rotate. Moreover, eitherrollers 492 or ratcheted rollers 504 may be used simply to gatherstomach surface tissue to allow for fastening, e.g., suturing, stapling,etc.

Pyloroplasty Tools and Methods

Creating a smaller gastric pouch within the stomach may be accomplishedby a variety of methods, as described above. To aid in the overalleffect for the treatment of obesity, a pyloroplasty procedure may alsobe performed to enhance treatment. The pyloroplasty may be performedprior to (preferable), in conjunction with, or following the gastricreduction procedure. A pyloroplasty procedure typically results in thepyloric sphincter being rendered incompetent. However, in the case oftreatments for GERD using the devices and methods described above, thepyloroplasty procedure as described herein may be omitted. Conventionalpyloroplasty procedures may typically be performed surgically or throughthe use of standard peripheral angioplasty balloons, e.g., in the 7 mmrange. However, in order to render a relatively healthy and normalpylorus permanently incompetent, a more aggressive procedure may beneeded.

To accomplish this generally, a pyloroplasty device may be passedendoscopically through the esophagus, into the stomach, and preferablyinto position in or across the pylorus. Energy or a stimulus is thenpreferably applied to the pylorus to render it incompetent. Energy maybe in the form of, e.g., heat, electrical, chemical, RF, etc., or acombination. Examples of chemical energy stimulus may comprise alcoholand sotrodecol. The stimulus may be in the form of, e.g., dilatation,cutting, ablation, viral, etc., or a combination. An example of a viralor chemical stimulus may be, e.g., a poison such as the botulinum toxintype A virus (Botox). An example of a method of use for Botox isdescribed in U.S. Pat. No. 5,437,291 to Pasricha et al., which isincorporated herein by reference in its entirety. An incompetent pylorusmay allow stomach contents to drain directly into the proximal duodenumwith minimal resistance. Moreover, some of the mentioned pyloroplastytreatments may be selected or designed to last only for a specific timeperiod, e.g., a week or several months, etc. For instance, the effectsof simple dilatation or the injection of Botox may be designed to renderthe pylorus incompetent for only a few months, which may be a desirabletime period for the patient to obtain the desired results of theprocedure.

Several examples of different possible variations on pyloroplastydevices are shown and described below. These variations are not intendedto be limiting but are merely given a's illustrative examples.

FIG. 30 shows an isometric view of one variation of a dilatation devicein balloon device 510 which may have angioplasty balloon 512 locatednear or at the distal end of catheter 514. Angioplasty balloon 512 maybe used alone to simply dilate the pylorus. Alternatively, exteriorballoon surface 516 may have at least one and preferably severalstimulating members 518 disposed about surface 516. Stimulating members518 are shown in the figure as cutting blades or wires, butalternatively, they may include electrodes, cryogenic dispensing probesor members, chemical dispensing probes, etc. Moreover, balloon 512 mayalternatively be a dilation wire basket similarly disposed withstimulating members 518.

FIG. 31 shows an isometric view of another variation in probe device520. Device 520 may have catheter or delivery member 524 with, e.g.,probes 526, which may extend from distal end 522. Although three probes526 are shown in the figure, at least one and up to several probes ofvarying thickness and lengths may be used. Probes 526 may be retractableso that during delivery through, e.g., the esophagus or stomach, probes526 may be withdrawn within distal end 522 and then extended whentreating the pylorus. Probes 526 may be electrically connected to avoltage or power source located outside the patient's body to deliverelectrical, RF, or heat energy to the pylorus. Alternatively, they maybe configured like a needle to deliver chemical or biological stimuli torender the pylorus incompetent. For example, probes 526 may be used toinject chemicals, e.g., alcohol, sotrodecol, or other ablativechemicals, or biological stimuli, e.g., Botox virus or some otherincapacitating virus, into the pylorus. Such stimulants may be carriedwithin distal end 522, delivery catheter 524, or they may also bedelivered from the proximal end of catheter 524 and injected through toprobes 526.

Other variations which may be used for the pyloroplasty procedure areshown in FIGS. 32A and 32B. FIG. 32A shows sphincterotome arm 530 havinga distal end 532. Arm 530 may be bent as shown to allow cutting member534 to be drawn between distal end 532 and a location proximal of distalend 532 along arm 530. Another variation is seen in FIG. 32B wheredelivery member 536 may have an arcuate support member 538′ to supportcutting member 540. The variations shown in FIGS. 32A and 32B may bedelivered via a catheter or endoscope trans-esophageally and through thestomach to the pylorus where either cutting member 534, 540 may be usedto cut or saw into the tissue in or around the pylorus to render itincompetent. These particular variations of sphincterotomes shown inFIGS. 32A and 32B may be manufactured by Medi-Globe Corporation, locatedin Tempe, Ariz.

FIG. 33 shows stomach 550 with a distal portion of the wall of thelesser curvature removed for clarity. Device 520 may be deliveredthrough esophagus 552 to a location proximal of pylorus 558, e.g., firstposition 554. If probes 526 were retracted during delivery, they maythen be extended, as shown. Distal end 522 of device 520 may be advancedto, e.g., second position 556, such that probes 526 may pierce pylorus558 to deliver the stimulus.

FIG. 34A shows an isometric view of another variation with combinationdevice 560. Device 560 may have housing 562 on the distal end ofdelivery catheter or endoscope 564. Housing 562 defines notch 566 whichmay be oriented perpendicularly relative to the longitudinal axisdefined by endoscope 564. Notch 566 preferably has a geometry largeenough to accommodate part of pylorus 558 and housing 562 may be taperedat its distal end to allow for easy insertion into the pylorus 558during the procedure. Within notch 566 may be cutting blade 568 and oneither side of blade 568 may be fasteners 570, e.g., individual anchors,staples, etc. In operation, FIG. 34B shows housing 562 and endoscope 564delivered through esophagus 552. The wall of stomach 550 is partiallycut away for clarity. Housing 562 may be inserted into pylorus 558, thennotch 566 is preferably aligned such that part of the pyloral sphincterlies within notch 566. Alternatively, the pyloral tissue may also bedrawn into notch 566 via a vacuum or grasping member. Once the pyloraltissue is within notch 566, cutting blade 568 may be actuated totraverse notch 566 and sever part of the tissue of pylorus 558.Fasteners 570 may then be deployed on either side of incision 572 toaffix the incised tissue. The number of incisions 572 may vary dependingupon the desired degree of pyloric disablement. Alternatively, aninflatable balloon may be attached on the back of notch 566 and inflatedto push housing 562 into apposition with pylorus 558 and causeinvagination of the tissue into notch 566.

Anastomosis Tools and Methods

In addition to the tools and methods described above for gastricreduction and pyloroplasty procedures, an additional anastomosis gastricbypass procedure may also be performed to further enhance treatment. Theanastomosis procedure may be performed preferably prior to, inconjunction with, or following the gastric reduction and pyloroplasty(if performed at all) procedures. In the case of treatments for GERDusing the devices and methods described above, the anastomosis procedureas described herein may be omitted. The procedure generally involvesendoscopically or laparoscopically creating a side-to-side anastomosispreferably from within the stomach and bowel and within the digestivetract. This procedure may be similar to the Roux-en-Y gastric bypass(RYGB) procedure but with minimal trauma. This procedure may alsoeffectively bypass food from the stomach, past a proximal portion of thebowel, and preferably directly into a lower portion of the bowel. Thisbypassed portion may be considered a malabsorption zone.

A representative and normal gastro-intestinal system of a person isshown in FIG. 35 for comparison. Stomach 580 is shown with pyloricsphincter 582 near gallbladder 584 and attached to the proximal sectionof duodenum 586. The distal section of duodenum 586 is attached to theproximal section of jejunum 588, the distal section of which is furtherattached to the proximal section of ileum 590. Ileum 590 is thenattached to ascending colon 592, which continues through to thetransverse colon (which has been removed for clarity), and then todescending colon 594 and finally to rectum 596.

A gastrointestinal system which may be modified by a preferableanastomosis procedure is shown in FIG. 36. Stomach 600 is shown in thisvariation as having been modified by creating modified pouch 602, whichmay be created by any of the methods and tools as described above.Esophagus 603 is preferably connected to a proximal end of pouch 602. Asdescribed above, the distal end of pouch 602 may be connected directlyto pylorus 604 or alternatively, may be a blind-ended pouch and pylorus604 is connected to the proximal end of duodenum 606. A firstanastomosis 608 may be created preferably between modified pouch 602 anda section of digestive tract either from the distal duodenum 606 orproximal jejunum 610. First anastomosis 608 may be located in a rangefrom about 20 to 50 cm from pylorus 604. A second anastomosis 614 may becreated preferably between a section of duodenum 606 and a section ofileum 612. The second anastomosis 614 may be located in a range fromabout 15 to 55 cm from pylorus 604 or about 150 to 200 cm down along thelength of the small intestines from pylorus 604. This procedure mayallow for drainage of secretions created by stomach 600 to pass throughpylorus 604 and secretions of bile and chyme from the pancreas andgallbladder 618 to pass through biliary duct 620 partly through duodenum606 and then through second anastomosis 614 and directly into distalileum 616 and out of the body. The bypassed stomach 600, pylorus 604,and proximal duodenum 606 may act as a malabsorption zone because sugarsand fats which might normally be mostly absorbed in this zone may now bedirectly passed into the distal duodenum 606 or proximal jejunum 610.

During the anastomosis procedure, both first and second anastomoses 608,614, respectively, may be created first. Duodenum 606 may then be closedoff between the two anastomoses 608, 614. Then, depending upon thelength and size of the resulting modified stomach 602, pylorus 604 maybe closed off or left open, depending upon the desired result and whichof procedures and tools are implemented. Finally, modified pouch 602 maybe created after the anastomoses procedures. Alternatively, modifiedpouch 602 may be created prior to the anastomoses procedures, againdepending upon the desired result and which of procedures and tools areimplemented. If modified pouch 602 were created first, then theanastomoses procedure may be reversed to essentially end with the sameresult.

A conventional RYGB procedure is generally performed through a 6-8 inchincision extending from the end of the breastbone to just above thenavel. However, the procedure described above may be performed entirelyendoscopically or laparoscopically. FIG. 37 shows an isometric view ofan assembly which may be utilized to achieve part of the procedure.Deployment device 630 may have anastomosis assembly 632 preferablyconnected by steerable length 634 to manipulation handle 636. Assembly632 may be steerable during insertion, preferably trans-esophageally andthrough the stomach, by steering grip 638 which may be located onmanipulation handle 636. Control by a physician or surgeon ofmanipulation handle 636 may be facilitated by handle 640.

Anastomosis assembly 632 may have stapler housing 644 configured to fitintimately with distal element 646 preferably by a magnetic force, theuse of which is described below. Distal element 646 is preferablytapered or rounded on one side and may have a coring anvil 648 on itsopposing side. Coring anvil 648 may be tapered or rounded and may fitintimately into coring mate 650 which is preferably located near or atthe center of stapler housing 644. Stapler housing 644 may also houseseveral staples loaded within staple slots 652, which may be disposedcircumferentially around coring mate 650 and may be actuated from theproximal end of length 634 by staple trigger 642.

FIG. 38 shows a cross sectioned view of anastomosis assembly 632 matedwith distal element 646 at first anastomosis 608 between modified pouch602 and jejunum 610. Part of the walls of modified pouch 602 and jejunum610 have been removed for clarity. In creating first anastomosis 608,distal element 646 may first be placed within the appropriate section ofjejunum 610. This may be done by orally passing distal element 646through the esophagus, stomach, and then through the duodenum. Distalelement 646 is preferably magnetized, either by manufacturing distalelement 646 from natural ferrous materials or artificially magnetizingit. Because of the magnetization, distal element 646 may be urgedthrough the body and into place within the duodenum by, e.g., magneticwands or magnetic pickups, which may be manipulated from outside thepatient's body.

During or after placement of distal element 646, stapler housing 644,which may be attached to steerable length 634, may be introducedtransesophageally into the stomach 602 and placed into position alongstomach wall 660 at the desired site of first anastomosis 608. Once bothstapler housing 644 and distal element 646 are in position, they maythen be coupled together preferably by the magnetic force and attractionbetween the two. Moreover, the two may be brought into alignment eitherby alignment grooves (not shown) or by the mating of coring anvil 648into coring mate 650. As the mating occurs, part of stomach wall 660 andintestinal wall 662 are preferably held or maintained between staplerhousing 644 and distal element 646. To enhance the mating, fasteners mayoptionally be deployed from stapler housing 644 through staple slots 652and preferably through both stomach wall 660 and intestinal wall 662into distal element 646. FIG. 38 shows staples 667 deployed asfasteners, but they may comprise any type of mechanical fasteners asdescribed above, as well as, e.g., grommet-type swages, snap lock fits,staples, screws, clips, and friction-fittings.

Once the fitting has been accomplished, the device may be left inapposition to maintain the position of stomach wall 660 and intestinalwall 662 for about one week. This may result in pressure necrosis of thetissue between stapler housing 644 and distal element 646 preferablycausing the serosal layers of the gut to fuse, at which point theassembly may drop out and be passed, preferably leaving firstanastomosis 608 behind. Alternatively, a coring device 664, which may beslidingly contained within stapler housing 644, may first be advancedthrough the center of stapler housing 644 and both stomach wall 660 andintestinal wall 662 to create first anastomosis 608. The remainingassembly may then be left to cause the pressure necrosis and fusing oftissue, as described. Another alternative may be to use stapler housing644 and distal element 646 as a mechanism for a conventional end-to-endanastomosis (EEA) stapler. In this case, once they are aligned, a rodmay be advanced through the center of the assembly to preferably lockdistal element 646 to intestinal wall 662. The rod may be drawn back,preferably pulling a distal stapler segment into stapler housing 644.This action may cause staples to fire and a circumferential blade to cutout the center of the staple ring, thereby creating an anastomosis.

To create second anastomosis 614, a similar approach may be taken as forcreating first anastomosis 608. An example of another magneticanastomosis device which may also be used in this procedure is shown anddescribed in U.S. Pat. No. 5,690,656 to Cope et al., which isincorporated herein by reference in its entirety. FIG. 39 shows aportion of duodenum 606 juxtaposed to a portion of ileum 612 and distalileum 616 with part of the intestinal walls removed for clarity. In thisvariation, proximal element 670 may be used and is preferably amagnetized mating element for distal element 646. Distal element 646 mayfirst be urged to the desired location preferably in ileum 612 by, e.g.,magnetic wands or magnetic pickups, which may be manipulated fromoutside the patient's body, in the same manner as above. During or afterplacement of distal element 646, proximal element 670 may also bedelivered or urged to the desired location in the same manner. Once bothelements 646, 670 are in position, they are preferably mated together bya magnetic force. The mating may optionally be enhanced by fasteners,e.g., staples 667, to hold both elements 646, 670 in position. Theintestinal wall inbetween may be cored, as described above, but it mayalso be simply left to undergo pressure necrosis between elements 646,670 eventually causing the serosal layers of the gut to fuse, at whichpoint elements 646, 670 may drop out and be passed, preferably leavingsecond anastomosis 614 behind.

The applications of the methods and tools discussed above are notlimited to the treatment of obesity, but may include any number offurther applications, e.g., GERD, which may involve manipulation of anorgan interior. Modification of the above-described methods and toolsfor carrying out the invention, and variations of aspects of theinvention that are obvious to those of skill in the art are intended tobe within the scope of the claims.

We claim:
 1. A device for forming a pouch within an interior of anorgan, comprising: a delivery member having a proximal end and a distalend; a curved tube attached to the distal end of the delivery member,the curved tube having a lumen, and having a first releasably adheringsection and a second releasably adhering section; a septum removablyattached to the curved tube to separate the first releasably adheringsection from the second releasably adhering section; and a fastenerdisposed within the lumen of the curved tube; wherein the first andsecond releasably adhering section of the curve tube position a firstarea of the interior in apposition with a second area of the interior,and wherein the fastener is deployed from the curved tube to fix thefirst area of the interior with the second area of the interior to formthe pouch.
 2. The device of claim 1, wherein the curved tube isC-shaped, U-shaped, or crescent shaped.
 3. The device of claim 1,wherein the first and second releasably adhering sections of the curvedtube include vacuum ports separated by the septum.
 4. The device ofclaim 1, wherein the first and second releasably adhering sections ofthe curved tube include a channel separated by the septum and a slotdisposed within the channel being in communication with a vacuum.
 5. Thedevice of claim 4, wherein the fastener may be fired though the slot andinto the first and second areas of the interior.
 6. The device of claim1, wherein the fastener is a staple.
 7. The device of claim 6, whereinthe staple includes a pivot.
 8. The device of claim 7, wherein thestaple is W-shaped.
 9. The device of claim 1, further including a wedgeslidingly positioned within the lumen of the curved tube, the wedgebeing adapted to urge the fastener from an open first configuration to aclosed second configuration.
 10. The device of claim 9, wherein thewedge further being adapted to push the septum along the curved tube.11. The device of claim 1, wherein the fastener is a staple.
 12. Thedevice of claim 11, wherein the staple includes a pivot.